Cardiometabolic Risk in Cardiac Rehab

Coronary Artery Disease Clinical Trial

Official title:

Cardiometabolic Risk in the Setting of Cardiac Rehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01985048
• Other study ID #: R2013-3102
• Status: Active, not recruiting
• Phase: N/A
• First received: November 5, 2013
• Last updated: February 12, 2015
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: February 2015
• Source: Health Diagnostic Laboratory, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

1. Primary Objectives:

• To characterize cardiometabolic risk factor profiles of patients entering cardiac rehab using traditional approaches (eg LDL-C) as well as a more comprehensive panel of cardiovascular and metabolic biomarkers. It is hypothesized that the comprehensive panel will identify further increased risk that would not have been detected using only traditional approaches. Specifically, it is hypothesized that a greater percentage of the cohort will be identified with "high risk" levels of LDL-P (>1100 nmol/L) and/or apoB (>80 mg/dL) than of LDL-C (>100 mg/dL). It is further hypothesized that the prevalence of elevated Lp(a) and elevated levels of inflammatory and insulin resistance markers will be higher in this cohort when compared to population norms (HDL, inc reference data).

• To assess improvements in laboratory and lifestyle risk factors and rate of goal attainment at completion of rehab (eg 3 months). This objective is primarily descriptive, and improvements in traditional risk factors (eg LDL-C) will be compared to existing published data. Improvements in non-traditional risk factors (eg LDL-P, insulin resistance markers) in a cardiac rehab population have not been extensively investigated.

• To determine which attributes at baseline best predicted recurrent events and re-hospitalizations assessed one year later.

2. Secondary/Developmental Objective:

• To inform and guide development of a subsequent study protocol designed to compare outcomes associated with biomarker-guided personalized treatment plans vs. standard of care in the cardiac rehab setting.

Description:

This pilot study will characterize risk factors of patients as they enter cardiac rehab, track how comprehensive biomarker profiles change during the normal course of rehab, and associate biomarkers at baseline with MACE outcomes assessed one year later. Blood draws, vitals, and patient medical histories will be collected as subjects enter rehab and at the end of the rehab program. Major adverse cardiac events will be assessed via phone interview at 12 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Known CAD/ IHD

• Eligibility for cardiac rehab following an acute coronary event; either:

• ST elevation myocardial infarction

• Non ST elevation myocardial infarction

• Angina

• CABG

Exclusion Criteria:

• Younger than 18 years old

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Holy Spirit Hospital and Health Center	Camp Hill	Pennsylvania
United States	Ephrata Community Hospital	Ephrata	Pennsylvania
United States	Lancaster Heart & Vascular Institution, Cardiac Rehab	Lancaster	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Health Diagnostic Laboratory, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

Ghashghaei FE, Sadeghi M, Mostafavi S, Heidari H, Sarrafzadegan N. The effect of the cardiac rehabilitation program on obese and non-obese females with coronary heart disease. Adv Biomed Res. 2012;1:17. doi: 10.4103/2277-9175.96077. Epub 2012 May 11. — View Citation

Gitt A, Jannowitz C, Karoff M, Karmann B, Horack M, Völler H. Treatment patterns and risk factor control in patients with and without metabolic syndrome in cardiac rehabilitation. Vasc Health Risk Manag. 2012;8:265-74. doi: 10.2147/VHRM.S28949. Epub 2012 Apr 24. — View Citation

Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16. — View Citation

Hammill BG, Curtis LH, Schulman KA, Whellan DJ. Relationship between cardiac rehabilitation and long-term risks of death and myocardial infarction among elderly Medicare beneficiaries. Circulation. 2010 Jan 5;121(1):63-70. doi: 10.1161/CIRCULATIONAHA.109.876383. Epub 2009 Dec 21. — View Citation

Kubilius R, Jasiukeviciene L, Grižas V, Kubiliene L, Jakubseviciene E, Vasiliauskas D. The impact of complex cardiac rehabilitation on manifestation of risk factors in patients with coronary heart disease. Medicina (Kaunas). 2012;48(3):166-73. — View Citation

Martin SS, Gosch K, Kulkarni KR, Spertus JA, Mathews R, Ho PM, Maddox TM, Newby LK, Alexander KP, Wang TY. Modifiable factors associated with failure to attain low-density lipoprotein cholesterol goal at 6 months after acute myocardial infarction. Am Heart J. 2013 Jan;165(1):26-33.e3. doi: 10.1016/j.ahj.2012.10.005. Epub 2012 Nov 17. — View Citation

Suaya JA, Stason WB, Ades PA, Normand SL, Shepard DS. Cardiac rehabilitation and survival in older coronary patients. J Am Coll Cardiol. 2009 Jun 30;54(1):25-33. doi: 10.1016/j.jacc.2009.01.078. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiometabolic biomarker risk factor		Change from Baseline at 3 months	No
Secondary	Major adverse cardiovascular events		one year	No